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Accelerated R&D ServicesThe Science of Getting Products to Patients Faster

Study Data Standardization Plan

Use Case Experience

Dave IzardMay 14, 2015

Client Use Case for Study Data Standardization Plan

• PreNDA Meeting Briefing Package for NCE– First discussion of clinical data details w/ FDA @ PreNDA meeting

• Thirteen Studies– 10 phase 1 (7 early, 3 recent)– 1 phase 2– 1 phase 3– 1 phase 3 extension

• Compound purchased from another company following 1st phase 1 study

© 2015 Accenture All Rights Reserved. 2

Goals for Study Data Standardization Plan

• Convey standards utilized at study level for clinical studies• Rationalize reason for limited legacy conversion• Rationalize decision for limited / no pooling of data


Section 2 – List of Studies (2.2 Clinical Studies)

• Study Status– No formal definitions available for planned, ongoing & completed– Agency decisions made based on concrete study start date– Sponsor wanted “Study Start Date” and “Study End Date” with available

check boxes of “planned” & “actual”, coupled with a formal agency definition for “Study End Date” in order to use this table



• Study Design / Trial Blinding Schema / Diagnosis Group / Indication Type / Study Type– Protocols & CSRs already written using company / industry conventions– No desire or willingness to restate these items using controlled

terminology after the fact– Concern about potential requirement to write this way in the future



• Submit Study Datasets– Decision to submit study datasets is independent of the characteristics of

a study– A simple “yes/no” response is of limited value

• Multiple submissions for ongoing studies?• Submission w/ CSR vs. SPA vs. NDA vs. 120DSU


Section 4 vs. Table Ultimately Produced




CRF annotation standards need to be taken into

consideration…

Data definition

file standards could be different

across data types…



Does this add value?

Transparent rationale for use of legacy standards…

Observations


Should probably remove hard version of Study Data TCG from

this section of document…

Observations

• This table only holds the information pertaining to the data utilized to support the original CSR

• Any assets created as the result of legacy conversion for other purposes are documented in a separate table


Observations

• Need to add context (e.g., Tabulation Data, Adverse Event Coding) between Study Identifier & Expected Standard


Study Data Standardization Plan• No mention of if / how / when pools

will be developed, submitted and potentially updated over time

• No mention of if / how / when individual studies will be submitted and potentially updated over time


Observations

Actions to Consider• Get FDA buy in that pooled data

standardization should be recorded in this same document

• Separate standardization versus submission strategy

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